Quality Audit Program Manager

Pay Range: $33.60hr - $38.60hr

Job Overview:

The Audit Program Manager performs the day-to-day administration of all processes related to internal and external audit. This role ensures that all Quality audit activities are being performed per released procedures. The candidate will ensure effective closure of internal and external audit findings by working with cross-functional departments and business partners to ensure comprehension, development, and execution of corrective and preventive action and evaluation of effectiveness checks. The successful candidate monitors the timely completion of all audit findings related to corrective action plans and coordinates the reporting of compliance metrics. The candidate will support the implementation and continuous improvement of the quality and regulatory compliance programs, including inspection readiness programs.

Responsibilities:

• Manage external audit administration activities, including coordination, logistics and preparation for external audits.
• Monitor the audit finding related activities as a result of internal and external audits to ensure timely completion.
• Develop and facilitate the reporting of external and internal audit related metrics to ensure compliance to internal procedure and external commitments.
• Execute the governance process to ensure timely and effective reviews of audit findings and visibility to Senior Management.
• Promotes a culture of compliance to regulations, standards, and procedures and risk management through monitoring and reporting process.
• Serve as key liaison for engineering change orders and Quality Management System project support.
• Lead and refine the internal audit module, including but not limited to: troubleshooting issues as needed and knowing when to escalate to IT, partnering with Training LMS Administrator to develop, improve and administer Audit Module training, providing group or individual training, and ensuring process changes per documented procedures in the Audit Module.
• Monitors and audits adherence to corporate policies as directed and investigates any violations, including coordinating investigations, audits, conducting interviews, and preparing reports.
• Lead other audit management related projects as required.

Requirements:

• Minimum Bachelor's Degree or equivalent years of experience, in Engineering, physical or biological science or other technical field.
• A minimum of 2-3 years of experience in a compliance role in the medical device industry.
• A working knowledge of project management tools and techniques.
• Knowledge of EU-MDR, ISO 13485:2016, Medical Device Single Audit (MDSAP), and 21 CFR 820 requirements, Health Canada, and other international regulatory requirements.
• Certified Quality Auditor or ISO lead Auditor Certification is desired.
• Demonstrated ability to effectively work with cross-functional and cross-plant project teams and work effectively with a variety of work groups.
• Experience interpreting and providing guidance on domestic and international regulations as applicable to the quality management system.
• Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment.
• Strong interpersonal skills with the ability to work closely with people at all levels within the organization and facilitate the implementation of corrective action.